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Full Text of this Amendment

SA 1009. Mr. HATCH submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the end of title II, insert the following:
Subtitle __Antibiotic Safety and Innovation

SEC. 2__. DEVELOPMENT OF ANTIMICROBIALS.
(a) Incentives for Development of New Antibiotics and New Antibiotic Uses.--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further amended by adding at the end the following:
``(r)(1) Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a drug that is the subject of an approved application described in paragraph (2) may elect to receive, with respect to the drug--
``(A)(i) the 3-year exclusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F); and
``(ii) the 5-year exclusivity period referred to under subsection (c)(3)(E)(ii) and under subsection (j)(5)(F)(ii); or
``(B) a patent term extension under section 156 of title 35, United States Code.
``(2) An application described under this paragraph is an application for marketing submitted under this section after the date of enactment of this subsection in which--
``(A) the drug that is the subject of the application contains an antibiotic drug; and
``(B) such antibiotic drug was the subject of an application received by the Secretary under section 507 of this Act (as in effect before November 21, 1997).
``(3) Paragraph (1) shall not be construed to entitle a drug that is the subject of an approved application described in paragraph (2) for any market exclusivities or patent extensions other than those exclusivities or extensions described in paragraph (1).''.
(b) Bioequivalence to Listed Antibiotic Drug.--Section 505(j)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(8)) is amended by adding at the end the following:
``(D) Notwithstanding any other provision of this subsection, an oral antibiotic drug that is not intended to be absorbed into the bloodstream shall be considered to be bioequivalent to a listed antibiotic drug only if--
``(i) clinical trials do not show a significant difference between the antibiotic drug and the listed antibiotic drug in safety and effectiveness; or
``(ii) the Secretary has--
``(I) established alternative, scientifically valid methods that are reasonably expected to detect a significant difference between the antibiotic drug and the listed antibiotic drug in safety and effectiveness;
``(II) developed the alternative, scientifically valid methods described in subclause (I) through notice and comment rulemaking in accordance with section 553 of title 5, United States Code; and
``(III) determined that, based on the alternative, scientifically valid methods described in subclauses (I) and (II), there is no significant difference between the antibiotic drug and the listed antibiotic drug in safety and effectiveness.''.
(c) Public Meeting.--The Commissioner of Food and Drugs shall convene a public meeting and, if appropriate, issue guidance regarding which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under subsection (a) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development.
(d) Grants and Contracts for the Development of Orphan Drugs.--Subsection (c) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:
``(c) For grants and contracts under subsection (a), there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2007, and $35,000,000 for each subsequent fiscal year.''.
SEC. 2__. ESTABLISHMENT OF ANTIMICROBIAL BREAKPOINTS.
(a) Definition.--In this section, the term ``antimicrobial breakpoint'' means specific values which characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or drugs) tested, such as Minimum Inhibitory Concentrations (MICs) or zones of inhibitions.
(b) Establishment of Breakpoints.--
(1) IN GENERAL.--The Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall direct the Commissioner of Food and Drugs to establish and periodically update antimicrobial breakpoints.
(2) REVIEW AND UPDATE.--Antimicrobial breakpoints shall be reviewed and updated as necessary pursuant to recommendations from the Antimicrobial Resistance Task Force and in consultation with the Centers for Disease Control and Prevention, or more frequently upon the discretion of the Commissioner of Food and Drugs, but in no case less than once every 5 years.
(c) Public Availability.--The Secretary shall direct the Commissioner of Food and Drugs to make antimicrobial breakpoints publicly available within 30 days of the date of establishment and any update under this section.
(d) Advisory Organizations.--The Commissioner of Food and Drugs may contract with an organization or organizations to aid in the establishment of antimicrobial breakpoints under this section in a manner not inconsistent with the Federal Advisory Committee Act (5 U.S.C. App.). The Commissioner of Food and Drugs shall make the final determination regarding establishments of antimicrobial breakpoints under this section.
SEC. 2__. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING ENANTIOMERS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 355), as amended by this subtitle, is amended by adding at the end the following:
``(s) Drugs Containing Enantiomers.--For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted under subsection (b) for a non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application under subsection (b), the single enantiomer shall not be considered the same active ingredient contained in the approved racemic drug, if--
``(1)(A) the single enantiomer has not been previously approved as an active ingredient except in the approved racemic drug; and
``(B) the application submitted under subsection (b) for the drug containing the single enantiomer includes full reports of investigations described in subsection (b)(1)(A) which do not rely on any investigations that are part of the application submitted under subsection (b) for approval of the approved racemic drug; and
``(2)(A) the application submitted under subsection (b) for the drug containing the single enantiomer is not submitted for approval of a use--
``(i) in a therapeutic area in which the approved racemic drug has been approved; or
``(ii) for which any other enantiomer of the racemic drug has been approved; or
``(B) in the case of an antibiotic drug, such drug is demonstrated through well-controlled clinical trials to be safe and effective for a use for which the racemic drug has not been approved and for which no other enantiomer of the racemic drug has been previously approved.''.

(As printed in the Congressional Record for the Senate on May 2, 2007.)